Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Recurrence

Disease Progression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Anti-Infective Agents

Antirheumatic Agents

Antineoplastic Agents

Hormones

Hydroxychloroquine

Abiraterone Acetate

Navitoclax

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

Abiraterone with both ABT-263 and Hydroxychloroquine

ARM A(Abiraterone with ABT-263) and ARM B(Abiraterone with both ABT-263 and Hydroxychloroquine)

Abiraterone

ABT-263

ARM B(Abiraterone with both ABT-263 and Hydroxychloroquine)

Robert DiPaola, MD

The purpose of this study is to assess the effect of combining abiraterone with medicines that may block some of the ways that cells become resistant to abiraterone. The investigators hope that these combinations of medicines will result in prostrate cancer cells dying.

This study will see if overcoming diseases resistance to abiraterone will restore sensitivity to androgen deprivation therapy.

Subjects will be either treated on one of the earlier dosing regimens or randomly assigned to one of two groups or ARMs of this study.

ARM A will receive Abiraterone with ABT-263.

ARM B will receive Abiraterone with both ABT-263 and Hydroxychloroquine

In the beginning of the study a total of 18 patients may get one of three dose levels. A total of nine (9) patients per each arm will be started at a low dose and given increasing doses if no side effects are seen. In this part of the study three patients will be enrolled at each dose level for each individual arm starting with Arm A followed by Arm B.

Navitoclax and Abiraterone Acetate With or Without Hydroxychloroquine in Treating Patients With Progressive Metastatic Castrate Refractory Prostate Cancer

A Phase II Study of ABT-263/Abiraterone (Arm A) or ABT-263/Abiraterone and Hydroxychloroquine (Arm B) in Patients With Metastatic Castrate Refractory Prostate Cancer (CRPC) and Progression Following Chemotherapy and Abiraterone

Characterize "biochemical response" to ABT-263 and Abiraterone and to ABT-263 in combination with hydroxychloroquine and Abiraterone by looking at PSA levels.

Rutgers Cancer Institute of New Jersey

National Cancer Institute (NCI)

AbbVie

Rutgers, The State University of New Jersey

Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily\* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily\*

\* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are \>50,000/mm3.

NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient.

ARM A - Dose Escalation

Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily\*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily\*, Hydroxychloroquine 400 mg po BID daily

\* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are \>50,000/mm3.

ARM B - Dose Escalation

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Mark Stein, MD

Abiraterone with ABT-263

Abiraterone: ARM A and ARM B

ABT-263: ARM A and ARM B

ARM A

Abiraterone with both ABT-263 and Hydroxychloroquine

Abiraterone: ARM A and ARM B

ABT-263: ARM A and ARM B

Hydroxychloroquine: ARM B

ARM B

Study was terminated early and insufficient data was collected to assess this outcome measure.

Biochemical Response to ABT-263 and Abiraterone and to ABT-263 in Combination With Hydroxychloroquine and Abiraterone in Patients That Are Progressing on Abiraterone

Study was terminated early and insufficient data were collected to assess this outcome measure.

Time to PSA Progression

Progression Free Survival

Study was terminated early and insufficent data was collected to assess this outcome measure.

Measurable Tumor Response in Patients With Measurable Disease

Circulating Tumor Cells Pre-enrollment and During Therapy

Study was terminated warly and insufficient data was collected to assess this outcome measure.

Spots Global Cancer Trial Database for Navitoclax and Abiraterone Acetate With or Without Hydroxychloroquine in Treating Patients With Progressive Metastatic Castrate Refractory Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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